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Serving leading biopharmaceutical companies globally:

US Army
Teva
Argus Health
UBS
Express Scripts
QuintilesIMS
Novartis
Farmers Insurance
Medtronic
Citi

Generated: October 20, 2017

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Nevirapine - Generic Drug Details

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What are the generic sources for nevirapine and what is the scope of nevirapine patent protection?

Nevirapine
is the generic ingredient in three branded drugs marketed by Aurobindo, Sandoz Inc, Aurobindo Pharma Ltd, Alvogen Malta, Apotex Inc, Mylan Pharms Inc, Boehringer Ingelheim, Prinston Inc, Cipla Ltd, Cipla, Mylan Labs, Tech Organized, Macleods Pharms Ltd, Micro Labs Ltd, Hetero Labs Ltd Iii, and Strides Pharma, and is included in twenty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nevirapine has thirty-two patent family members in twenty-seven countries and five supplementary protection certificates in five countries.

There are twenty drug master file entries for nevirapine. Twenty-one suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: nevirapine

US Patents:1
Tradenames:3
Applicants:16
NDAs:25
Drug Master File Entries: see list20
Suppliers / Packagers: see list21
Bulk Api Vendors: see list77
Clinical Trials: see list199
Patent Applications: see list5,525
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nevirapine at DailyMed

Tentative approvals for NEVIRAPINE

Applicant Application No. Strength Dosage Form
u► Subscribe50MGTABLET; ORAL
u► Subscribe200MGTABLET; ORAL
u► Subscribe200MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 2011ABRXYesYes► Subscribe► Subscribe ► Subscribe
Cipla Ltd
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL206448-001Oct 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo
NEVIRAPINE
nevirapine
TABLET;ORAL077521-001May 22, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
VIRAMUNE
nevirapine
TABLET;ORAL020636-001Jun 21, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Aurobindo
NEVIRAPINE
nevirapine
SUSPENSION;ORAL077702-001May 22, 2012AARXNoNo► Subscribe► Subscribe► Subscribe
Alvogen Malta
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL204621-002Nov 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
VIRAMUNE
nevirapine
SUSPENSION;ORAL020933-001Sep 11, 1998AARXYesYes► Subscribe► Subscribe► Subscribe
Mylan Labs
NEVIRAPINE
nevirapine
TABLET;ORAL078864-001May 22, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL206879-001Oct 6, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Tech Organized
NEVIRAPINE
nevirapine
TABLET;ORAL203176-001May 22, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
VIRAMUNE
nevirapine
SUSPENSION;ORAL020933-001Sep 11, 1998► Subscribe► Subscribe
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 2011► Subscribe► Subscribe
Boehringer Ingelheim
VIRAMUNE
nevirapine
TABLET;ORAL020636-001Jun 21, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: nevirapine

Country Document Number Estimated Expiration
Spain2574836► Subscribe
Israel199924► Subscribe
Morocco31430► Subscribe
Japan5417662► Subscribe
Tunisia2009000510► Subscribe
Peru03712009► Subscribe
South Korea20100020447► Subscribe
EcuadorSP099561► Subscribe
Taiwan200916127► Subscribe
China101784263► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NEVIRAPINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/020United Kingdom► SubscribePRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
C0021Belgium► SubscribePRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
/1999Austria► SubscribePRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
C0019France► SubscribePRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
90022Netherlands► SubscribePRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Federal Trade Commission
Medtronic
Cipla
Queensland Health
Johnson and Johnson
Chubb
Baxter
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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